BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRONOVA* POLY (HEXAFLUOROPROPYLENE - VDF) SUTURE

    MDR report key: 3950279 · Received July 22, 2014

    Report

    Report Number
    2210968-2014-09786
    Event Type
    Malfunction
    Date Received
    July 22, 2014
    Date of Event
    June 27, 2014
    Report Date
    June 30, 2014
    Manufacturer
    ETHICON INC.
    Product Code
    GAW
    PMA / PMN Number
    K001625
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CONCLUSION: TO DATE, THE DEVICE HAS NOT BEEN RETURNED. IF THE PRODUCT IS RETURNED FOR EVALUATION, ANY FURTHER INFO DERIVED FROM THE EVALUATION WILL BE SUBMITTED IN A SUPPLEMENTAL 3500A FORM.

    Additional Manufacturer Narrative · 1

    CONCLUSION: ACTUAL SAMPLE WAS RETURNED FOR EVALUATION. DETACHED SUTURE WAS NOT RECEIVED. VISUAL EXAMINATION OF THE DETACHED NEEDLE WAS FOUND TO HAVE CORRECT SWAGE AND GOOD SWAGE COMPRESSION. NO CONCLUSION CAN BE DRAWN AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE OBTAINED, A SUPPLEMENTAL 3500A FORM WILL BE SUBMITTED ACCORDINGLY. CONCLUSION: REPRESENTATIVE SAMPLES WERE RETURNED FOR EVALUATION. THE SAMPLES WERE VISUALLY AND FUNCTIONALLY EVALUATED AND THE SAMPLES MET REQUIREMENTS. IN ADDITION, A REVIEW OF THE BATCH MANUFACTURING RECORDS WAS CONDUCTED AND THE BATCH MET ALL FINISHED GOODS RELEASE CRITERIA.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT A SURGICAL PROCEDURE ON (B)(6) 2014 AND SUTURE WAS USED. DURING ANASTOMOSIS AND WHEN THE SURGEON APPLIED A LITTLE TENSION TO THE NEEDLE, THE SUTURE PULLED OFF OF THE NEEDLE AT THE SWAGE PART. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE WITH NO ADVERSE PATIENT CONSEQUENCES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    428583 PRONOVA* POLY (HEXAFLUOROPROPYLENE - VDF) SUTURE SUTURE, NON ABSORBABLE, SYNTHETIC GAW ETHICON INC. UNK GLR192

    Patients

    Seq Age Sex Outcome Treatment
    1